Specialist, QA

Location
Summit West, NJ, United States
Posted
Sep 17, 2020
Ref
R1529373
Required Education
Bachelors Degree
Position Type
Full time
At Bristol Myers Squibb, we are inspired by a single vision - transforming patients' lives through science.In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

Position

Specialist, Quality Assurance Disposition

Manager

Manager, Quality Assurance Disposition

Division

CTDO Quality Assurance

Grade

D04

Direct Reports

N/A

Location

Summit, NJ

Prerequisites (As Applicable)

B.S. degree required, minimum of two years of experience in the pharmaceutical or related industry.

Purpose and Scope of Position

The Specialist is responsible for quality and disposition activities in accordance with Celgene policies, standards, procedures and Global cGMP. Functional responsibilities include performing incoming material release and product release, ensuring accurate and timely maintenance and review of manufacturing batch record documentation, and performing document issuance for manufacturing.

Required Competencies: Knowledge, Skills and Abilities
  • Must have advanced knowledge and experience with cGMP manufacturing, Quality, and compliance.
  • Directs quality initiatives that accomplish continuous improvement and enhance site quality system efficiencies.
  • Must be action-oriented and customer-focused and skilled in decision-making, building relationships, problem solving, conflict management, planning and organizing, resource allocation, coaching others, and analytical thinking.
  • Requires moderate direction to complete more complex tasks; completes routine tasks with little or no supervision.
  • Work is self-directed.
  • Confident in making decisions for non-routine issues.
  • Routinely recognizes and resolves Quality issues; Informs management of proposed solutions. Seeks management guidance on complex issues. Develops procedures.
  • Proposes solutions for complex issues and works with management to resolve. Follows established procedures and performs work as assigned.
  • Intermediate to advanced ability to interpret results and situations and articulate recommendations for resolution.
  • Understands continuous improvement and improves efficiency and productivity within the group or project.
  • Contributes to goals within the work group.
  • Able to recognize conflict and notify management with proposed recommendations for resolution.
  • Able to prepare written communications and communicate problems to management with clarity and accuracy.
  • Able to effectively multi-task.
  • Knowledge of US and global cGMP requirements.
  • Excellent verbal and written communication skills.


Duties and Reponsibilties
  • Responsible for disposition of incoming production materials.
  • Responsible for release activities for site manufactured drug product.
  • Review and approval of executed batch records.
  • Issue production batch records and product labels to Operations.
  • Must have ability to author and critically review investigations, interpret results and generate technical conclusions consistent with Quality risk management principles.
  • Must be skilled in planning and organizing, decision-making, and building relationships.
  • Knowledge of quality processes, including material disposition, change control, product complaints, deviations, investigations, and CAPA management.


Education and Experience

B.S. degree required, minimum of two years of experience in the pharmaceutical or related industry. Equivalent combination of education and experience acceptable.

Working Conditions: (US Only)

Work is performed in a typical office environment, with standard office equipment available and used. Work is generally performed seated, but may require standing and walking for up to 10% of the time. Lighting and temperature are adequate and there are no abnormal conditions caused by noise, dust, etc.

DEFINITIONS AND ABBREVIATIONS (As Applicable)

This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.

This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.